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A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer

NCT06315491 · Cybrexa Therapeutics
In plain English

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Official title
A Randomized Phase 2 Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
About this study
The purpose of this study is to assess the safety, tolerability, and efficacy of CBX-12 in female subjects with platinum resistant or refractory ovarian cancer at 2 doses; 125 mg/m2 every 21 days or 100 mg/m2 every 21 days.
Eligibility criteria
Inclusion Criteria: * Subjects must have histologically- or cytologically-diagnosed epithelial high-grade serous cancer of the ovary, fallopian tube cancer or primary peritoneum cancer that is refractory to prior therapy and must have platinum-resistant disease defined as: * Subjects who have received only 1 platinum-based chemotherapy regimen for at least 4 cycles of platinum must have disease progression on treatment or occurring ≤ 26 weeks after their last dose of platinum. * Patients who have progressed following a second course of a platinum based regimen. * Subjects may have up to 2 additional systemic regimens for advanced or metastatic disease. Maintenance regimens (e.g., with a PARP inhibitor or bevacizumab) are not considered separate regimens. * Age greater than or equal to 18 years at the time of signing the informed consent form (ICF). * Has measurable disease per RECIST 1.1. * Has provided written informed consent. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Adequate liver, renal, hematologic, pulmonary and coagulation function. Exclusion Criteria: * Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapy within 3 weeks prior to the first dose of CBX-12. * Subjects who are currently receiving any other anticancer or investigational agent(s). * Clinically significant intercurrent disease. * Active human immunodeficiency virus (HIV) infection. * Active hepatitis B or C infection.
Study design
Enrollment target: 40 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-09-25
Estimated completion: 2025-10
Last updated: 2025-10-06
Interventions
Drug: CBX-12
Primary outcomes
  • Percentage of Subjects With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] (Randomization to progressive disease (PD) (Up to approximately 21 months))
Sponsor
Cybrexa Therapeutics · industry
Contacts & investigators
ContactClinical Operations Trial Team · contact · clinicalstudies@cybrexa.com · 860-717-2731
InvestigatorMichael Needle, MD · study_director, Cybrexa Therapeutics
All locations (17)
Honor HealthWithdrawn
Scottsdale, Arizona, United States
Arizona Oncology AssociatesActive Not Recruiting
Tucson, Arizona, United States
Usc Norris Comprehensive Cancer CenterActive Not Recruiting
Los Angeles, California, United States
Yale University School of MedicineActive Not Recruiting
New Haven, Connecticut, United States
D&H Cancer Research CenterActive Not Recruiting
Margate, Florida, United States
South Florida GynecologyActive Not Recruiting
Tampa, Florida, United States
Northwest Cancer CentersWithdrawn
Dyer, Indiana, United States
Norton Cancer InstituteActive Not Recruiting
Louisville, Kentucky, United States
Women's Cancer CareActive Not Recruiting
Covington, Louisiana, United States
Pci Nyu Langone HealthActive Not Recruiting
New York, New York, United States
Albert Einstein College of Medicine Montefiore MedicalActive Not Recruiting
New York, New York, United States
University Hospitals Seidman Cancer CenterActive Not Recruiting
Cleveland, Ohio, United States
Oncology Associates of OregonActive Not Recruiting
Eugene, Oregon, United States
Allegheny Singer Research Institute D/B/A Ahn Research InstitutionRecruiting
Pittsburgh, Pennsylvania, United States
Mary Crowley Cancer ResearchRecruiting
Dallas, Texas, United States
Texas Oncology- Gulf CoastActive Not Recruiting
The Woodlands, Texas, United States
Multicare Institute For Research & InnovationActive Not Recruiting
Tacoma, Washington, United States
A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer · TrialPath